The 2022 Monkeypox (Mpox) outbreak, initially detected in the United Kingdom, posed a significant global health challenge. The World Health Organization’s declaration of a Public Health Emergency of International Concern underscored the urgency of the situation. In Nigeria, the National Agency for Food and Drug Administration and Control (NAFDAC) took proactive measures to ensure the timely availability of a safe and effective vaccine. The agency granted Emergency Use Authorization (EUA) to the JYNNEOS vaccine in August 2023, a crucial step in the nation’s public health response. The EUA was subsequently extended in July 2024 based on additional data and the fulfillment of specific conditions.
The EUA Process: A Collaborative Approach
NAFDAC’s approach to the mpox vaccine EUA was characterized by collaboration and reliance on international regulatory bodies. The agency worked closely with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), leveraging their assessments and expertise. This reliance mechanism allowed NAFDAC to expedite the review process without compromising the rigor of its evaluation. The agency also engaged with the manufacturer, Bavarian Nordic A/S, and the National Primary Health Care Development Agency (NPHCDA) to ensure the vaccine’s quality, safety, and effective deployment. The collaborative efforts extended to post-authorization surveillance, with NAFDAC and NPHCDA working together to monitor the vaccine’s distribution and use.
Key Considerations for EUA and Extension
NAFDAC’s decision to grant and subsequently extend the EUA was based on a comprehensive assessment of the JYNNEOS vaccine’s quality, safety, and efficacy. The agency scrutinized the manufacturing process, quality control measures, and clinical data. The vaccine’s safety profile was evaluated in various populations, including individuals with HIV and atopic dermatitis. The efficacy assessment initially relied on immunogenicity data and animal challenge studies. However, for the extension, NAFDAC also considered real-world effectiveness data submitted by the manufacturer, which further supported the vaccine’s ability to protect against mpox. The agency also considered the risk-benefit balance, concluding that the benefits of the vaccine outweighed its potential risks.
Conditions of Authorization and their Fulfillment
NAFDAC’s EUA for the JYNNEOS vaccine was not unconditional. The agency imposed several conditions to ensure the vaccine’s continued safety and efficacy monitoring. The manufacturer was required to submit periodic safety update reports, including data on adverse events and any new safety signals. This condition was met, as evidenced by the submission of the 21st Periodic Benefit-Risk Evaluation Report (PBRER) covering the period up to January 31, 2024. NAFDAC also mandated the implementation of a robust pharmacovigilance system to monitor the vaccine’s performance in the Nigerian population. Additionally, the agency initially requested further data on the vaccine’s effectiveness in the Nigerian context. This condition was partially fulfilled through the submission of a systematic literature review summarizing real-world effectiveness studies conducted since the 2022 mpox outbreak.
Conclusion: NAFDAC’s Role in Safeguarding Public Health
NAFDAC’s handling of the mpox vaccine EUA and its subsequent extension demonstrates its commitment to safeguarding public health in Nigeria. The agency’s collaborative approach, reliance on international regulatory bodies, and rigorous assessment process ensured the timely availability of a safe and effective vaccine. The conditions imposed on the EUA and their subsequent fulfillment further emphasize NAFDAC’s dedication to ongoing safety and efficacy monitoring. As Nigeria continues to grapple with the challenges of infectious diseases, NAFDAC’s role in regulating vaccines and other medical products remains critical. The agency’s evidence-based approach and commitment to transparency inspire confidence in the safety and efficacy of the medical products available to the Nigerian people.
Mpox (Monkeypox) Outbreak: Global trends map
